Process Validation Engineer

작업 내용

This is a contract as a Consultant (employee or freelance)

We are looking for a Process Validation Engineer, for one of our clients based in Braine-l’Alleud.

As a Process Validation Engineer, your main tasks will be:

Technical Validation lead main tasks are:

• to collaborate with business and quality partners in order to
• Ensure follow up of clean utilities, cleaning, environmental monitoring PQ.
• Participate in QE investigations.
• to actively support all project activities as required.
• to track project execution by using appropriate KPIs.

General

• Ensure validation activities meet the B7 global schedule.
• Participate in reviewing / writing project validation procedures, master plan, verification summary reports and plans.
• Be agile to support C&V and validation team based on project priorities.

Commissioning & Verification / ValidationWrite/review and approve test plans and related protocols (FAT, SAT, etc.) to ensure documented evidence to requirements.

• Write/review and approve reports related to test protocols. Ensure punch list / defects / Change Control are appropriately managed.
• Lead commissioning/verification and testing activities, follow execution until closure of related changes and defects.
• Assist with Validation Protocol writing and execution. Support for Validation Deviations.

System acceptance and release

• Write and approve release reports for GMP use of systems.

Technical stewardship

• Support troubleshooting and resolution of any issue.
• Manage technical discussion on all deviations, changes, design issues and test failures by involving appropriate SMEs.
• Escalate to management any issues that cannot be solved by the team.

Quality

• Ensure project procedures are understood and applied.
• Ensure that decisions are based on scientific evidence/rationale and that level of documentation is commensurate to the level of risk.
• Ensure documents are controlled, executed and filled into a high standard.
• Update, Review and Approve technical specifications (URS), quality risk assessment, design verification report or any other documents impacted by changes or defects identified during C&V/Validation activities.
• Promote continuous improvement within the C&V team and the project team by escalating any pertinent observation.
• Liaise with quality partners.

Safety

• Ensure all safety measures have been appropriately implemented prior to any C&V activities.
• Make sure all tests are well planned and supervised by appropriately trained, inducted and technically competent staff.
• Ensure that project procedures are understood and applied.
• Liaise with safety partners.

Transition to operations

• Effective use of the commissioning and verification phase to integrate operators and technicians into the team to make sure that operation staff become familiar with the equipment/system.
• Organizing equipment/system training prior to handover with support of vendors.

Requirements

We expect this requirements for the position of Process Validation Engineer:

• Master’s Degree
• Technical expertise in biotech equipment or systems related to their package (minimum 5 years’ experience in engineering or manufacturing environment)
• Ability to work in highly dynamic environment and to handle challenging situations
• High communication skills (leadership, negotiation, change management, facilitation)
• Decision making ability and high sense of responsibility
• Ability to challenge and argument
• Fluent in French
• Good knowledge of English is a plus

Our offer

For this position of Process Validation Engineer, we offer an attractive salary with extra-legal advantages:

• Group insurance
• Hospitalisation insurance
• Meal vouchers of 7 euros gross per working day
• Reimbursement km or company car
• Monthly allowance (80 euros net per month)
• A 13th month
• Training
• Etc.

A rate as a freelancer is also possible.